Quality Engineer 2

Job Title Quality Engineer 2 Job Description Execute as a Quality Engineer (Q&R) for the newly acquired Philips manufacturing facility in Minnesota. You will support site Business Units in transfer, installation and validation, beginning with a Class III combination device. Your role: Lead on Active Risk Management Data collection and reporting. Support the non-conforming material process and the Materials Review Board Support problem -solving teams through root cause investigations and failure analysis to implementation and final verification. Ensure Risk Management is effective utilizing feedback from validation, post market surveillance, manufacturing indicators, NCMR’s, CAPAs, HHEs, etc. Support Quality Improvement projects for the site, including formal quality efforts such as CAPA, NCMR, OOS and Audit Responses. Develop, implement and monitor quality metrics. Communicate status and progress. Support systems for maintaining manufacturing quality (e.g. Review of equipment / records). You're the right fit if: You’ve acquired 2 years of experience in the medical device or pharmaceutical industry Your skills include experience with FDA requirements 21 CFR 820, knowledge of regulations such as GLP, GMP, ISO 13485 and other international regulatory requirements and proficiency with statistical software package (Minitab & JMP) You have a bachelor’s degree in engineering, life sciences or other related field or equivalent work experience You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others. Learn more about our business. Discover our rich and exciting history. Learn more about our purpose. Read more about our employee benefits. If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here. Additional Information US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future. Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Plymouth, MN. Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace. Embrace the unexpected Frederik and Gerard Philips started a small light bulb company in Eindhoven. Little did they realize that it would become a global force of innovation, committed to improving billions of lives worldwide. But it did. Today, Philips is a world leading health technology company with a vision to make life better for people worldwide through meaningful innovation. Making good on this promise depends on our passionate, inspirational, collaborative and diverse team. We have over 80,000 brilliant people around the world but are always looking for more. Like-minded, motivated, focused minds to join us in creating a healthier, more connected society while transforming themselves personally and professionally. Working at Philips is more than a job. It’s an experience filled with unexpected moments that will transform you in lasting and positive ways. Help us improve the world for the better while building a career that no one could have planned for. Even you. It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws. As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance. Equal Employment and Opportunity Employer/Disabled/Veteran EEO Is The Law and Supplement Poster | Pay Transparency Nondiscrimination Statement